Safety of N -Acetylcysteine at High Doses in Chronic Respiratory Diseases: A Review
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REVIEW ARTICLE
Safety of N‑Acetylcysteine at High Doses in Chronic Respiratory Diseases: A Review Peter Calverley1 · Paola Rogliani2 · Alberto Papi3 Accepted: 13 November 2020 © The Author(s) 2020
Abstract N-Acetylcysteine (NAC) is widely used in respiratory medicine, with a maximum licensed dose in chronic use of 600 mg/day; however, some clinical trials have studied the efficacy of NAC at higher doses. The aim of this review was to evaluate the adverse effects profile of NAC at higher than the standard dose in chronic respiratory diseases to establish a risk–benefit ratio in increasing the daily dose; therefore, studies using NAC at a dose of at least 600 mg/day were selected. Forty-one articles where NAC has been used at 600 mg and above, up to 3000 mg/day, and with a specific report on safety, were considered. Most of the studies used oral NAC and were conducted on patients with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchiectasis, chronic bronchitis and cystic fibrosis. In general, the safety profile was similar at both the high and standard doses with the oral formulation; gastrointestinal symptoms were reported but they were no more common than in the control group. Key Points N-Acetylcysteine (NAC) has several indications and can be used in respiratory medicine [chronic obstructive pulmonary disease (COPD), interstitial lung diseases such as idiopathic pulmonary fibrosis (IPF), bronchiectasis, and influenza], and has been used worldwide for over 50 years. When treatment requires chronic use, as in COPD and cystic fibrosis, the maximum licensed dose is 600 mg/ day, but doses > 600 mg daily have been studied in some clinical trials. Studies of high doses of NAC (up to 3000 mg/day) in respiratory diseases with explicit reports on safety found that NAC was safe and well tolerated. In general, the safety profile is similar at both the high and standard doses. * Alberto Papi [email protected] 1
School of Aging and Chronic Disease, University of Liverpool, Liverpool, UK
2
Department of Experimental Medicine, University of Rome “Tor Vergata”, Rome, Italy
3
Section of Cardiorespiratory and Internal Medicine, Department of Medical Sciences, Research Centre on Asthma and COPD, University of Ferrara, Ferrara, Italy
1 Introduction N-Acetylcysteine (NAC) has been used worldwide for over 50 years. It has several indications and can be used in respiratory medicine [chronic obstructive pulmonary disease (COPD), interstitial lung diseases such as idiopathic pulmonary fibrosis (IPF), bronchiectasis, and influenza], as an antidote for paracetamol poisoning, and in contrastinduced nephropathy (CIN), psychiatric and neurological illnesses, and addictive behaviours [1–6]. NAC administered intravenously at a total dose of 300 mg/kg can be safely used to prevent liver necrosis in cases of paracetamol (acetaminophen) poisoning [6, 7]. It has also been safely used at high doses to limit CIN [2, 3, 8–10]). In both situations, high doses of NAC are administrated for a relatively brief period
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